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Simultaneous Pancreas-Kidney and Sequential Pancreas-After-Kidney Transplantation

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Title: Simultaneous Pancreas-Kidney and Sequential Pancreas-After-Kidney Transplantation.

Agency: Agency for Health Care Policy and Research/Center for Health Care Technology (Formerly, the Office of Health Technology Assessment).

Contact: Thomas V. Holohan, M.D., Director, CHCT.

Status: Technology Assessment: Published, 1995.

Language: English.

Primary Objective: To evaluate the safety, efficacy, effectiveness and cost-effectiveness of simultaneous pancreas-kidney (SPK) and pancreas-after-kidney (PAK) transplantation.

Methods Used: Comprehensive review of published articles addressing SPK and PAK, and the construction of a model for cost-effectiveness analyses (CEA) for both procedures.

Data Identification: (a) MEDLINE search using terms "renal transplantation," "pancreas transplantation," "human," "quality of life," and "cost-effectiveness"; (b) review of bibliographies of published reports on SPK/PAK; (c) review of a published bibliography of 3,206 articles addressing cost-effectiveness studies; (d) publication of a Federal Register notice of the assessment with solicitation of information on the topic; (e) letter soliciting data sent to every U.S. medical center which performed SPK or PAK.

Study Selection: Editorials, letters to editors, case reports were excluded; published material which attended to observations not directly related to safety, effectiveness, cost-effectiveness and clinical utility of SPK/PAK were excluded (e.g., data regarding posttransplant infection prophylaxis, methodologies for detecting rejection, detailed posttransplant metabolic and biochemical evaluations, imaging techniques for evaluating rejection, etc.); all reports of primary data addressing results of SPK/PAK were reviewed, but the assessment emphasized reports published after 1989; transplant registry data (e.g., UNOS) were included; all information received in response to the Federal Register notice and direct requests to transplant centers was reviewed. A total of 95 published articles were included in the assessment bibliography.

Data Extraction: Type of study (e.g., RCT, case series, etc.); size of sample; patient selection criteria; graft and patient survival; effectiveness (secondary complications of diabetes, quality of life); cost/charge/payment data; comparison to renal transplant alone (KTA) with continued insulin therapy.

Key Findings: Patient selection criteria were not explicit, although it appears that many SPK/PAK recipients have had mild or moderate clinical problems with hyper- or hyperglycemia. Pancreas graft survival averaged 74%, 71%, and 64% at 1-3 yrs. posttransplant. Morbidity following SPK or PAK is significantly greater than that following renal transplant. Objective data do not support the contention that secondary complications of diabetes are improved or stabilized following SPK/PAK. Quality of life studies have produced highly variable results, and the reliability of that data are questionable. Cost data are elusive; the CEA model employed in the assessment indicated that SPK/PAK is likely to be cost effective compared to KTA only when employed in diabetics whose total annual cost for treatment of complications of hyper- or hypoglycemia are in the range of $10,000-$15,000 per annum or higher.

Conclusions: Prospective studies of SPK/PAK including explicit patient selection criteria and measures of effectiveness are needed. Objective data should address the change in QOL subsequent to transplant, and the instruments used to measure QOL should be more uniform and have demonstrated validity and reliability. Much more cost data should be made available to permit valid and reliable CEA.

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